Minocycline Hydrochloride

Product NDC: 67877-436
11-digit product format: 678770436
Labeler code: 67877
Product ID: 67877-436_51213aa1-873c-4b55-a36d-3ebbb73fa220
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Minocycline Hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Ascend Laboratories, LLC
Application: ANDA204453
Marketing category: ANDA
Marketing start: 2019-12-23
Substance: MINOCYCLINE HYDROCHLORIDE
Active strength: 55 mg/1
Pharmacologic classes: Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 8 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204453-001	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-002	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-003	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-004	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28
A204453-005	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28
A204453-006	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16
A204453-007	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16
A204453-008	MINOCYCLINE HYDROCHLORIDE	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 8 matching rows.

Application-product, TE code table
Application-product	TE code
A204453-001	AB
A204453-002	AB
A204453-003	AB
A204453-004	AB
A204453-005	AB
A204453-006	AB
A204453-007	AB
A204453-008	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-001	MINOCYCLINE HYDROCHLORIDE	EQ 45MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-002	MINOCYCLINE HYDROCHLORIDE	EQ 80MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-003	MINOCYCLINE HYDROCHLORIDE	EQ 90MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-004	MINOCYCLINE HYDROCHLORIDE	EQ 105MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-005	MINOCYCLINE HYDROCHLORIDE	EQ 135MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2016-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-006	MINOCYCLINE HYDROCHLORIDE	EQ 65MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2018-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-007	MINOCYCLINE HYDROCHLORIDE	EQ 115MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2018-03-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-008	MINOCYCLINE HYDROCHLORIDE	EQ 55MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-12-19	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 9 · 324 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204453-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-006	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-007	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204453-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-006	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-007	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204453-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204453-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-006	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-007	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204453-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-006	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-007	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204453-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-006	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-007	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204453-008	AB	1	`b8a1b40f171c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Minocycline Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MINOCYCLINE HYDROCHLORIDE	55 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0020414E5U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
629695	Internal RxNorm lookup
629697	Internal RxNorm lookup
629699	Internal RxNorm lookup
858062	Internal RxNorm lookup
858372	Internal RxNorm lookup
1013659	Internal RxNorm lookup
1013662	Internal RxNorm lookup
1013665	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a8f95207-b259-4f50-87f2-3652d9268890	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d9c90ddb-dcc8-42af-a94b-505e4488bdc7	Product name	1	20250623
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9e423e97-a6d9-7bb0-0dcb-343af7c0ff92	Product name	2	20230322
472a6924-c7ed-850b-32ce-a510e887fbf9	Product name	4	20230207
f1239550-2d2e-44c3-aec7-14fd9b4ab55d	Product name	1	20201103
7a57513a-a145-4b95-9165-1e0ef21d6017	Product name	1	20200326
70555e58-6951-4421-9354-f80c6ce0d92c	Product name	7	20200204
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
23de08d7-aa4e-ec8b-ce6d-2124a855e4ef	Product name	5	20180605
76736e48-254d-4a39-993d-206efbdaad1d	Product name	1	20170717
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
0c498039-5512-d9d7-e6b6-833de47219ff	Product name	2	20151106
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67877-436-01	Minocycline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100	20
67877-436-05	Minocycline Hydrochloride	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500	20
67877-436-14	Minocycline Hydrochloride	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	20
67877-436-14	Minocycline Hydrochloride	14 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	14	20
67877-436-30	Minocycline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-436-30	EA - Each	67877-436	e38b5e5b-7258-4ad5-b553-8cad4e537c53	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-436	MINOCYCLINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [ASCEND LABORATORIES, LLC]	16	Current NDC, Legacy NDC, 5 package rows	20220908_a8f95207-b259-4f50-87f2-3652d9268890.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3e74e8a3-2670-97f5-e063-6394a90a361e	2026-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3e796794-b731-61d6-e063-6394a90aa9b3	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	c11bfea8-6079-44ce-b8e1-20bfba631bec	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	6e0efd1a-5a09-4030-8fe2-f98334cdeb0e	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	9c43389b-dc98-41f3-80bf-73d916ad6843	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	409dddb0-be3a-4ae3-ab39-88a6cd50a219	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	b3236a5c-8a5d-4d5d-9656-aee72a4c482b	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	a16012ce-5754-4177-bfb7-dcce696a7189	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	99825095-d897-4077-86df-483d505615b2	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	493bdeac-e073-4ec2-a481-85e6a6d3cb58	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	74946a91-b138-42cd-a9d4-58fe8f849270	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	653b22f3-9eb5-4c29-9b95-bc1c4f0273be	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	e1611d28-0c96-4ce2-ad5d-f62f66ec164d	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Ascend Laboratories, LLC	a8f95207-b259-4f50-87f2-3652d9268890	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453 ndc (product): 67877-436
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	e69284bc-0479-48d0-beb5-a26cfad6cd76	2025-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	2688e63a-09c7-4d73-a923-cf14fec7b1a4	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	ddd22f2c-050b-4776-912b-39b3e6202c75	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	9f4139e4-d4ab-46ea-a3f1-f719ab57a55e	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	084fb405-fcb9-4db9-8d95-5a9c1d89f3b6	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453
Minocycline Hydrochloride	MINOCYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	100b48e9-0884-4112-b9aa-cb6f07c28756	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204453 application number: ANDA204453

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0020414E5U	MINOCYCLINE HYDROCHLORIDE	13614-98-7	MINOCYCLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1013662	minocycline HCl 55 MG 24HR Extended Release Oral Tablet	PSN	a0f88292-680b-4d50-ae6e-0a7bccc3a9c6	106
1013662	24 HR minocycline 55 MG Extended Release Oral Tablet	SCD	a0f88292-680b-4d50-ae6e-0a7bccc3a9c6	106
1013662	minocycline 55 MG 24 HR Extended Release Oral Tablet	SY	a0f88292-680b-4d50-ae6e-0a7bccc3a9c6	106
1013662	minocycline HCl 55 MG 24HR Extended Release Oral Tablet	PSN	493bdeac-e073-4ec2-a481-85e6a6d3cb58	102
1013662	24 HR minocycline 55 MG Extended Release Oral Tablet	SCD	493bdeac-e073-4ec2-a481-85e6a6d3cb58	102
1013662	minocycline 55 MG 24 HR Extended Release Oral Tablet	SY	493bdeac-e073-4ec2-a481-85e6a6d3cb58	102
1013659	minocycline HCl 105 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
858062	minocycline HCl 115 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
629695	minocycline HCl 135 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
629697	minocycline HCl 45 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
1013662	minocycline HCl 55 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
858372	minocycline HCl 65 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
1013665	minocycline HCl 80 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
629699	minocycline HCl 90 MG 24HR Extended Release Oral Tablet	PSN	a8f95207-b259-4f50-87f2-3652d9268890	20
1013659	24 HR minocycline 105 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
858062	24 HR minocycline 115 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
629695	24 HR minocycline 135 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
629697	24 HR minocycline 45 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
1013662	24 HR minocycline 55 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
858372	24 HR minocycline 65 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
1013665	24 HR minocycline 80 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
629699	24 HR minocycline 90 MG Extended Release Oral Tablet	SCD	a8f95207-b259-4f50-87f2-3652d9268890	20
1013659	minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
1013659	minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
1013659	minocycline 105 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
858062	minocycline 115 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
858062	minocycline 115 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
629695	minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
629695	minocycline 135 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
629697	minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
629697	minocycline 45 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
1013662	minocycline 55 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
858372	minocycline 65 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
858372	minocycline 65 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
1013665	minocycline 80 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
629699	minocycline 90 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
629699	minocycline 90 MG 24 HR Extended Release Oral Tablet	SY	a8f95207-b259-4f50-87f2-3652d9268890	20
1013659	minocycline HCl 105 MG 24HR Extended Release Oral Tablet	PSN	3e796794-b731-61d6-e063-6394a90aa9b3	1
858062	minocycline HCl 115 MG 24HR Extended Release Oral Tablet	PSN	3e796794-b731-61d6-e063-6394a90aa9b3	1
629695	minocycline HCl 135 MG 24HR Extended Release Oral Tablet	PSN	3e796794-b731-61d6-e063-6394a90aa9b3	1
629697	minocycline HCl 45 MG 24HR Extended Release Oral Tablet	PSN	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013662	minocycline HCl 55 MG 24HR Extended Release Oral Tablet	PSN	3e796794-b731-61d6-e063-6394a90aa9b3	1
858372	minocycline HCl 65 MG 24HR Extended Release Oral Tablet	PSN	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013665	minocycline HCl 80 MG 24HR Extended Release Oral Tablet	PSN	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013659	24 HR minocycline 105 MG Extended Release Oral Tablet	SCD	3e796794-b731-61d6-e063-6394a90aa9b3	1
858062	24 HR minocycline 115 MG Extended Release Oral Tablet	SCD	3e796794-b731-61d6-e063-6394a90aa9b3	1
629695	24 HR minocycline 135 MG Extended Release Oral Tablet	SCD	3e796794-b731-61d6-e063-6394a90aa9b3	1
629697	24 HR minocycline 45 MG Extended Release Oral Tablet	SCD	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013662	24 HR minocycline 55 MG Extended Release Oral Tablet	SCD	3e796794-b731-61d6-e063-6394a90aa9b3	1
858372	24 HR minocycline 65 MG Extended Release Oral Tablet	SCD	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013665	24 HR minocycline 80 MG Extended Release Oral Tablet	SCD	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013659	minocycline 105 MG (26.25 MG Immediate Release Beads / 78.75 MG Extended Release Beads) 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013659	minocycline 105 MG (as minocycline HCl 113.4 MG) 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013659	minocycline 105 MG 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
858062	minocycline 115 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
858062	minocycline 115 MG 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
629695	minocycline 135 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
629695	minocycline 135 MG 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
629697	minocycline 45 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
629697	minocycline 45 MG 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013662	minocycline 55 MG 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
858372	minocycline 65 MG (as minocycline hydrochloride) 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
858372	minocycline 65 MG 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1
1013665	minocycline 80 MG 24 HR Extended Release Oral Tablet	SY	3e796794-b731-61d6-e063-6394a90aa9b3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-436-01	67877043601	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-436-01)		2019-12-23	0000-00-00	No	No	Current
67877-436-05	67877043605	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-436-05)		2019-12-23	0000-00-00	No	No	Current
67877-436-14	67877043614	10 BLISTER PACK in 1 CARTON (67877-436-14) / 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	10 blister pack	2019-12-23	0000-00-00	No	No	Current
67877-436-30	67877043630	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (67877-436-30)		2019-12-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Minocycline Hydrochloride	PD-Rx Pharmaceuticals, Inc.	2026-07-31	HUMAN PRESCRIPTION DRUG LABEL	23
Minocycline Hydrochloride	Bryant Ranch Prepack	2026-03-25	HUMAN PRESCRIPTION DRUG LABEL	102
Minocycline Hydrochloride	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2025-12-18	Human Prescription Drug Label	20
Minocycline Hydrochloride	Bryant Ranch Prepack	2025-07-03	HUMAN PRESCRIPTION DRUG LABEL	106